Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT03450733
Eligibility Criteria:
Inclusion Criteria:
To be included in Group 1, subjects must meet all of the following criteria:
1. Has been implanted with appropriate components of the WMT MOM THA System
2. Has previously undergone primary THA for any of the following:
1. non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
2. inflammatory degenerative joint disease including rheumatoid arthritis;
3. correction of functional deformity.
3. Is willing and able to complete required study visit(s) and assessments
4. Plans to be available for the required study visit
5. Is capable of providing sufficient blood for sampling according to blood draw procedures
6. Is willing to sign the approved Informed Consent document
Previously implanted bilateral subjects can have both THAs enrolled in the study provided: 1) the specified combination of components were implanted in both, 2) all other aspects of the Inclusion/Exclusion Criteria are satisfied, 3) enrollment does not exceed the subject count specified in the Clinical Trial Agreement and protocol enrollment strategy, and 4) the subject agrees to a second Informed Consent document and data collection specific to the second THA. Enrollment and treatment of a previously unimplanted hip is not permitted in this study.
To be included in Group 2, subjects must meet all of the following criteria:
1. Does not have a metal implant (total hip, total knee, spinal, etc.) with the exception of dental implants
2. Is not an employee of the Investigator
3. Is willing and able to provide Informed Consent document
4. Is willing and able to attend the requested study visit(s) and assessments
5. Is capable of providing sufficient blood for sampling according to blood draw procedures
Exclusion Criteria:
Subjects will be excluded from either study group if they meet any of the following criteria:
1. Subject is currently enrolled in another clinical investigation which could affect the endpoints of this protocol
2. Subject is unwilling or unable to sign the Informed Consent document
3. Subject has documented substance abuse issues
4. Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
5. Subject is currently incarcerated or has impending incarceration
6. Group 1 only: Subject has a condition or previously implanted medical device that contraindicates MRI (e.g. pacemaker, implantable defibrillator)
7. Group 1 only: Subject was skeletally immature (less than 21 years of age) at time of implantation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT03450733
Study Brief:
Protocol Section:
NCT03450733